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NCT02370862 · ClinicalTrials.gov registry record · Early Phase 1
Transdermal Administration of a Prokinetic Agent for Bowel Evacuation in Persons With SCI
A Early Phase 1 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT02370862 is a Early Phase 1 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 28 participants.
The verdict
NCT02370862, a Early Phase 1 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this Phase I, proof of concept pilot study, the investigators propose to study the effectiveness of this medicine when it is delivered through the skin. In order to make delivery more efficient, the investigators will be using a technique called iontophoresis, which uses a mild electric current to drive the drug through the surface of the skin. The instrument includes an electrode containing the active agent (delivers charge) and an oppositely charged electrode (receives charge) which will be placed on the surface of the skin. The study design will consist of a screening visit to determine each individual's response to a previously established IV dose of NEO and GLY, followed by a dose titration study (two visits) of iontophoresed NEO and GLY. Study visits will be separated by no less than 2 days and no more than 14 days. If this delivery method is shown to be effective, it may represent a way to vastly improve the clinical utility of this medication by allowing for needle-free self administration, and expanding the clinical indication to routine, at home bowel care.
Interventions
- DRUG Neostigmine and Glycopyrrolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02370862
The ClinicalTrials.gov registry entry for NCT02370862 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neostigmine and Glycopyrrolate is the first listed.
NCT02370862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02370862 about?
NCT02370862 is a clinical study titled "Transdermal Administration of a Prokinetic Agent for Bowel Evacuation in Persons With SCI". Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the inve...
What is the current status of trial NCT02370862?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2013-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02370862?
The interventions under investigation include: Neostigmine and Glycopyrrolate (DRUG).
Who is sponsoring clinical trial NCT02370862?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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